N
nunziale
Hi folks,
I'm pretty new to regulatory affairs but would like to understand whether, for the sake of the MDD 93/42/EEC, a mobile app that uses games to motivate patients to do physical therapy exercises at home would be considered a medical device or not?
My understanding is that "motivating" has nothing to do with the actual therapy supply, although it is for the benefit of the patient. But I'm not sure if it may interfere with the "dosage" of that therapy and thus have an influence worth qualifying the app as a medical device.
Any hint on this?
Thanks
I'm pretty new to regulatory affairs but would like to understand whether, for the sake of the MDD 93/42/EEC, a mobile app that uses games to motivate patients to do physical therapy exercises at home would be considered a medical device or not?
My understanding is that "motivating" has nothing to do with the actual therapy supply, although it is for the benefit of the patient. But I'm not sure if it may interfere with the "dosage" of that therapy and thus have an influence worth qualifying the app as a medical device.
Any hint on this?
Thanks